Maximum Strength Betadine Clear Spray
FDA Label NDC 67618-183

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Atlantis Consumer Healthcare, Inc. for the product Maximum Strength Betadine Clear (NDC 67618-183). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding drug facts, purpose, uses, warnings, do not use, ask a doctor before use if you have, stop use and ask a doctor if, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active ingredients

Benzalkonium Cl 0.13%

Pramoxine HCl 1.0%

Purpose

First aid Antiseptic

Topical analgesic

Uses

First aid to help prevent infection and relieve pain or discomfort in minor

  • cuts
  • scrapes
  • burns

Warnings

For external use only

Do Not Use

  • in the eyes
  • over large areas of the body

Ask A Doctor Before Use If You Have

  • deep or puncture wounds
  • serious burns
  • animal bites

Stop Use And Ask A Doctor If

  • condition or symptoms get worse or last more than 1 week
  • Symptoms clear up and occur again within a few days

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away at 1-800-222-1222.

Directions

  • adults and children 2 years of age and older:
  • clean the affected area
  • spray a small amount of this product on the area 1 to 3 times daily
  • may be covered with sterile bandage
  • if bandaged, let dry first
  • children under 2 years of age:
  • consult a doctor

Other Information

  • protect from freezing

Inactive Ingredients

citric acid anhydrous, disodium edetate, flavor, propylene glycol, purified water, sodium citrate dihydrate.

Package Label.Principal Display Panel

Principal Display Panel


MAXIMUM STRENGTH

BETADINE® CLEAR

FIRST AID SPRAY

Pain Relieving

Antiseptic

Cleansing spray

  • ✓Ideal for Minor Cuts, wounds, scrapes & Burns
  • ✓Kills 99.9% of Germs* To prevent Infection
  • ✓Maximum Strength Pain Relief
  • ✓No Stinging or Burning

    • 6 FL OZ (177 mL)

    Dist. by: Atlantis Consumer Healthcare Inc.

    Bridgewater, NJ 08807 USA

    www.betadine.com

    ©2023 Atlantis Consumer Healthcare Inc.

    *commonly associated with skin infections.

    Tamper-Evident: Do not use if imprinted shrink band is broken or missing.

    Betadine is a registered trademark of Atlantis Consumer Healthcare Inc.

* Please review the disclaimer below.